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Study of Bosutinib in Japanese Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

Last updated on March 25, 2019

FOR MORE INFORMATION
Study Location
Fujita Health University Hospital
Toyoake-City, Aichi, 470-1192 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Myelogenous Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Diagnosis of CP CML of ≤6 months (from initial diagnosis); Diagnosis of CP CML with
molecular confirmation by detection of BCR-ABL rearrangement at screening (cytogenetic
assessment for Ph is not required for enrollment; however, patients with known Ph- CML
prior to registration are not eligible for this study)

- Age ≥20 years

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

- Adequate Liver and Renal Function

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Any prior medical treatment for CML, including TKIs, with the exception of hydroxyurea
treatment, which is permitted for up to 6 months prior to registration

- Any past or current CNS involvement, including leptomeningeal leukemia

- Extramedullary disease only

- Major surgery or radiotherapy within 14 days prior to registration

- History of clinically significant or uncontrolled cardiac disease

- Patients with active, uncontrolled bacterial, fungal, or viral infection

- Recent or ongoing clinically significant GI disorder

- History of another malignancy within 5 years prior to registration

- Uncontrolled hypomagnesemia or uncorrected hypokalemia due to potential effects on the
QT interval

- Known prior or suspected severe hypersensitivity to study drugs or any component in
their formulations

- Participation in other studies involving investigational drug(s) within 30 days or 5
half-lives of investigational product, whichever is longer, prior to registration
and/or during study participation

- Other severe acute or chronic medical or psychiatric condition, including recent or
active suicidal ideation or behavior, or laboratory abnormality that may increase the
risk associated with study participation or interfere with the interpretation of study
results

- Investigational site staff members directly involved in the conduct of the study and
their family members, or Pfizer employees, including their family members, directly
involved in the conduct of the study

NCT03128411
Pfizer
Active, not recruiting
Study of Bosutinib in Japanese Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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